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A Non-Interventional Follow Up Study For Subjects Who Received Sildenafil for Persistent Pulmonary Hypertension of the Newborn (PPHN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01801982
First received: January 8, 2013
Last updated: December 2, 2014
Last verified: December 2014
Results First Received: December 2, 2014  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: Pulmonary Hypertension, Persistent, of the Newborn
Intervention: Other: non-interventional

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All participants who received sildenafil treatment during study A1481276 (NCT01069861) were eligible for enrollment in this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Sildenafil Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.

Participant Flow:   Overall Study
    Sildenafil  
STARTED     1  
COMPLETED     0  
NOT COMPLETED     1  
Lost to Follow-up                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS) included all enrolled participants.

Reporting Groups
  Description
Sildenafil Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.

Baseline Measures
    Sildenafil  
Number of Participants  
[units: participants]
  1  
Age  
[units: years]
Mean ± Standard Deviation
  1.2  ± NA [1]
Gender  
[units: participants]
 
Female     1  
Male     0  
[1] Standard Deviation was not reported as only 1 participant was evaluated.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Physical Examination Abnormalities at Month 12   [ Time Frame: Month 12 ]

2.  Primary:   Number of Participants With Physical Examination Abnormalities at Month 24   [ Time Frame: Month 24 ]

3.  Primary:   Number of Participants With Clinically Significant Medical History at Month 12   [ Time Frame: Month 12 ]

4.  Primary:   Number of Participants With Clinically Significant Medical History at Month 24   [ Time Frame: Month 24 ]

5.  Secondary:   Overall Survival at Month 12   [ Time Frame: Month 12 ]

6.  Secondary:   Overall Survival at Month 24   [ Time Frame: Month 24 ]

7.  Secondary:   Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)   [ Time Frame: Up to Month 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Results at Month 24 were not reported as the participant lost to follow-up after Month 12.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01801982     History of Changes
Other Study ID Numbers: A1481283, 2010-021266-30
Study First Received: January 8, 2013
Results First Received: December 2, 2014
Last Updated: December 2, 2014
Health Authority: United States: Food and Drug Administration